Apparatus and Method for Intraoperative Assessment of Aortic or Pulmonary Valve Repair
An apparatus that enables the surgeon to pressurize and visually inspect the valve to assess the efficacy of the surgical repairs
Background
The semilunar (i.e., pulmonary and aortic) valves of the heart perform the critical task of regulating the flow of blood leaving the heart. Each year, tens of thousands of patients in the US undergo surgeries to repair valve dysfunctions. A major challenge in surgical repair of these valves is that the intra-operative (i.e., unpressurized and emptied) state of the valve is quite different from the physiological (pressurized) state. As a consequence, the surgeon has to rely on preoperative ultrasound images to assess the cause of the valve dysfunction. Moreover, assessment of the effectiveness of a surgical repair may require multiple repetitions of cardiac reperfusion and cardiopulmonary bypass, increasing the morbidity and mortality risks.
Technology Overview
Boston Children’s Hospital researchers have invented an apparatus that enables the surgeon to pressurize and visually inspect the valve to assess the efficacy of the surgical repairs intra-operatively. One instance of the invention consists of a tube which is inserted into the transected aorta or pulmonary artery. The tube has a lens at one end and is open at the other end. Pressurized sterile saline is delivered, either manually or using a pump, through a port on the side of the tube in order to fill the valve. A second port bleeds the air from the tube. To enhance the valve visibility, a light source can be retrofitted. An alternative implementation of the invention enables endoscopic inspection of the pressurized valve. In this implementation, valve pressurization will be the same as the first instance, but a longer tube is used with a port for an endoscope at its distal end.
The invention was tested on explanted porcine hearts. All steps of inserting the device in the aorta and securing it, pressurizing the valve, and endoscopically visualizing the pressurized valve were easily completed in under one minute. The experiment showed that the device was useful for intraoperatively assessing the valve immediately before and immediately after a surgical repair. The device was also successfully used to measure valve leaflet coaptation height in the pressurized state.
Further Details:
Berra, Ignacio G., et al. "An intraoperative test device for aortic valve repair." The Journal of Thoracic and Cardiovascular Surgery 157.1 (2019): 126-132.
Benefits
- Reduces surgery times
- Improves the efficiency of surgical workflow by reducing the likelihood of ineffective repairs
- Low manufacturing cost
- Easy to use
- Easy to adapt to patients with different aorta sizes
Applications
- Aortic valve reconstruction
- Pulmonary valve reconstruction
- Valve-sparing aortic root replacement
- Ross procedure
Patents
IP Status
- Patent application submitted
